Prone Position in Non-Invasive Ventilation and High-Flow Oxygen Therapy (ProPNIVFlow)

Hospital General Universitario Morales Meseguer

Status: Unknown

Conditions: Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure

Treatments: Device: Prone position during non-invasive respiratory support

Study type: Interventional

Funder types: Other

Identifiers

NCT04306107

10-03-2020 2 (Other Identifier)

10-03-2020

Details and patient eligibility

About

The aim of this trial is to study the effect of prone position during NIV and HFNC on acute hypoxemic respiratory patients.

Full description

Inclusion Criteria:

Adult patients with:

• ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level)

Exclusion Criteria

• General NIV or HFNC contraindications
• Immediate need for IOT
• Prone position intolerance
• Patients refusal to participate

Interventions:

• Prone position for 2-4 hours twice a day, for 3 days (first 3 days since admission to ICU)
• Nurse surveilance: at least every 15 minutes

Outcomes:

• Need for IOT
• Effects on the measurements specified above (particularly PaO2/FiO2)

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with:

  • ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level)

Exclusion criteria

• General NIV or HFNC contraindications
• Immediate need for IOT
• Prone position intolerance
• Patients refusal to participate

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups, including a placebo group

NIV with prone position

Experimental group

Description:

Use of prone position during NIV

Treatment:

Device: Prone position during non-invasive respiratory support

NIV (conventional)

Placebo Comparator group

Description:

NIV on conventional position

Treatment:

Device: Prone position during non-invasive respiratory support

HFNC on prone position

Experimental group

Description:

Prone position during HFNC

Treatment:

Device: Prone position during non-invasive respiratory support

HFNC (conventional)

Placebo Comparator group

Description:

HFNC on conventional position

Treatment:

Device: Prone position during non-invasive respiratory support